Extractables, Leachables & Elemental Impurities 2018 - West Coast

November 13-14, Sheraton La Jolla, CA

This two-day conference will examine the safety, quality, and regulatory issues involved in a wide array of contexts central to the pharmaceutical industry, including drug packaging and delivery components, single-use systems, and parenteral drug products. We will hear from key industry working groups such as PQRI and BPOG. In addition, we will focus closely on the keys to satisfying recent ICH and USP guidelines for metal impurities in current and future drug products and biologics.

2018 Cleaning Validation Summit

Pharma-Ed Exclusive

Cleaning Standards For Drugs and Devices From Industry Experts

September 12-13, 2018, Philadelphia, PA

Are you up to speed on the Science, Risk and Statistics based approaches for Cleaning Validation? Today's regulators are now asking for,
and expecting, ADE Monographs and Risk Assessments of Cleaning Validation Programs. This two-day, intensive summit brings together
the industry leaders on science and risk and statistics based cleaning.

Transdermal and Intradermal Drug Delivery Systems, 2018

Advanced Design, Development, and Delivery of Skin-Mediated Therapies and Vaccines

September 6-7, 2018, Racquet Club of Philadelphia, PA

The growing interest in alternative routes of drug administration has experts predicting that the market for transdermal and intradermal drug delivery systems will exceed $30 billion by 2020. The industry is on the threshold of bringing into commercial production a new generation of transformative TDD and IDD therapies and delivery systems. That is why you cannot afford to miss this two-day intensive conference. Pharma Ed brings together leading researchers in the field to share the most recent advances in the design, formulation, and delivery of skin-mediated therapies and vaccines.

Over 16 Featured Speakers, Including:

Conor O'Mahony, Tyndall National Institute

Lisa Dick, 3M

Harvinder Gill, Texas Tech

Yasmine Gomaa, Georgia Tech

Ajay Banga, Mercer University

Narasimha Murthy, Ole Miss

Jon Lenn, MedPharm, Inc.

Soo Hyeon Shin, FDA

With Comprehensive Coverage on:

Product Development and Quality Control Expectations with Respect to Transdermal and Topical Systems

Process Validation Summit 2018

May 17-18, Racquet Club of Philadelphia, PA

Are you compliant with FDA requirements for process validation? Today's regulators are applying more fine-grained specifications and demanding more sophisticated procedures for planning, executing, and documenting your processes throughout a drug product's lifecycle. This two-day intensive summit brings together industry leaders to help you exceed regulatory thresholds and avoid costly FDA inspection findings.

2018 Pre-Filled Syringes Forum

April 3-4, 2018, Racquet Club of Philadelphia, PA

With the Pre-Filled Syringes market expected to top $16 billion dollars by 2021, the industry is looking for next generation materials, technologies and production strategies to streamline commercialization and to adapt quickly to a changing regulatory environment. Pharma Ed Resources, an industry leader since 2004 in delivering market-driven research on PFS, is proud to announce its 2018 Pre-Filled Syringes Forum. Pharma Ed brings together top scientists, regulatory experts and innovators to share best practices and the latest research in this field, enabling you to maximize your organizationâ€™s leverage in this dynamic and growing market.

Extractables, Leachables & Elemental Impurities 2018

March 28-29, Racquet Club of Philadelphia, PA

This two-day conference will examine the safety, quality, and regulatory issues involved in a wide array of contexts central to the pharmaceutical industry, including drug packaging and delivery components, single-use systems, and parenteral drug products. We will hear from key industry working groups such as PQRI and BPOG. In addition, we will focus closely on the keys to satisfying recent ICH and USP guidelines for metal impurities in current and future drug products and biologics.

Pharma Analytics Summit

Statistical Approaches for Improving Performance and Compliance

March 26-27, 2018, Racquet Club of Philadelphia, PA

Use of statistics has been part of the FDAâ€™s guidances and regulations for many years. Use of statistics is an integral part of the Jan 2011 FDA Process Validation Guidance. It can be argued that the FDA is looking for the pharma and biotech industries to make even greater use of statistical thinking and methods. Are you compliant with FDA requirements? Todayâ€™s regulators are applying more fine-grained specifications and demanding more sophisticated procedures for planning, executing, and documenting your processes throughout a drug productâ€™s lifecycle. This two-day intensive summit brings together industry leaders to help you exceed regulatory thresholds and avoid costly FDA inspection findings.

With Representation From:

Eli Lilly

SynoloStats

Snee Associates LLC

JnJ Vision Care

Upsher-Smith Laboratories

Apotex

Janssen

Insight, Advice and Solutions, LLC

Excellent Pharma Consulting

Catalent Biologics

Zinata

With Comprehensive Coverage On:

Solving Statistical Mysteries â€“ What Does the FDA Want?

Stability and Capability of Measurement System and Manufacturing Process is Fundamental to Pharmaceutical Quality Assurance in the 21st Century

Strategies forAccelerating Process and Formulation Validation

Measurement Systems Analysis and Some Useful Experimental Designs

Continued Process Verification and Fit for Use Statistical Approaches

The Need for both Fundamental and Advanced Understanding to Design Lean Statistical Approaches

2017 Pre-Filled Syringes Forum

December 7-8, 2017, La Jolla, CA

With the Pre-Filled Syringes market expected to top $16 billion dollars by 2021, the industry is looking for next generation materials, technologies and production strategies to streamline commercialization and to adapt quickly to a changing regulatory environment. Pharma Ed Resources, an industry leader since 2004 in delivering market-driven research on PFS, is proud to announce its 2017 Pre-Filled Syringes Forum. Pharma Ed brings together top scientists, regulatory experts and innovators to share best practices and the latest research in this field, enabling you to maximize your organization's leverage in this dynamic and growing market.

Transdermal and Intradermal Drug Delivery Systems, 2017

Advanced Design, Development, and Delivery of Skin-Mediated Therapies and Vaccines

September 28-29, 2017, Racquet Club of Philadelphia, PA

The growing interest in alternative routes of drug administration has experts predicting that the market for transdermal and intradermal drug delivery systems will exceed $25 billion by 2018. The industry is on the threshold of bringing into commercial production a new generation of transformative TDD and IDD therapies and delivery systems. That is why you cannot afford to miss this two-day intensive conference. Pharma Ed brings together leading researchers in the field to share the most recent advances in the design, formulation, and delivery of skin-mediated therapies and vaccines.

Featuring Representation From:

Pfizer

Merck

Corium

3M

MIT

UCSB

Queens University, Belfast

Georgia Tech

Texas Tech

University of Mississippi

University of Cincinnati

Mercer University

University of Maryland

QPS

Intertek

Eurofins Lancaster Labs

ISYN Consulting

Zosano Pharma

With Comprehensive Coverage on:

Improving Bioavailability Via Transdermal Administration

Latest Advances in Microneedle Drug and Vaccine Delivery

How to Move from Passive to Active Skin-Mediated Delivery Technologies for Drugs and Biologics

Cleaning Validation Summit 2017

October 2-3, 2017, Racquet Club of Philadelphia, PA

Are you compliant with FDA requirements for cleaning validation? Today's regulators are applying more fine-grained specifications and demanding more sophisticated procedures for planning, executing, and documenting your processes throughout a drug product's lifecycle. This two-day intensive summit brings together industry leaders to help you exceed regulatory thresholds and avoid costly FDA inspection findings.

Process Validation Summit 2017

May 18-19, 2017, Philadelphia, PA

Are you compliant with FDA requirements for process validation? This two-day intensive summit brings together industry leaders to help you exceed regulatory thresholds and avoid costly FDA inspection findings.

With Representation From:

FDA

Abbott

Bayer

Genzyme

GSK

QPharma

Patheon

Pfizer

Arlenda

Snee Associates

PharmaTech Associates

Compliance Team Inc

ResMedica

Stat4Ward

Takeda

BergumSTATS

TARIS Biomedical

Tunnell Consult

Featuring Comprehensive Coverage On:

FDA Process Validation and Risk Management Approaches

Lifecycle Approach to Process Validation

Global Technology Transfer and Process Validation

Achieving the Business and Compliance Benefits of Quality by Design (QbD) and Continued Process Verification (CPV)

2017 Pre-Filled Syringes Forum

April 10-11, 2017, Racquet Club of Philadelphia, PA

With the Pre-Filled Syringes market expected to top $16 billion dollars by 2021, the industry is looking for next generation materials, technologies and production strategies to streamline commercialization and to adapt quickly to a changing regulatory environment. Pharma Ed Resources, an industry leader since 2004 in delivering market-driven research on PFS, is proud to announce its 2017 Pre-Filled Syringes Forum. Pharma Ed brings together top scientists, regulatory experts and innovators to share best practices and the latest research in this field, enabling you to maximize your organization's leverage in this dynamic and growing market.

Extractables, Leachables, & Elemental Impurities 2017

March 6-7, 2017, Racquet Club of Philadelphia

Attention to leachables, extractables, and elemental impurities has increased due to the recent revisions of USP and ICH guidelines, as well as the upcoming revisions to three major ISO 10993 standards. This two-day conference will examine the safety, quality, and regulatory issues involved in a wide array of contexts central to the pharmaceutical industry, including drug packaging and delivery components, single-use systems, and parenteral drug products. We will hear from key industry working groups such as PQRI and BPOG. In addition, we will focus closely on the keys to satisfying recent ICH and USP guidelines for metal impurities in current and future drug products and biologics.

Transdermal and Intradermal Drug Delivery Systems, 2016

Advanced Design, Development, and Delivery of Skin-Mediated Therapies and Vaccines

September 12-13, Racquet Club of Philadelphia, PA

The growing interest in alternative routes of drug administration has experts predicting that the market for transdermal and intradermal drug delivery systems will exceed $30 billion in 2016. The industry is on the threshold of bringing into commercial production a new generation of transformative TDD and IDD therapies and delivery systems. That is why you cannot afford to miss this two-day intensive conference. Pharma Ed brings together leading researchers in the field to share the most recent advances in the design, formulation, and delivery of skin-mediated therapies and vaccines.

Cleaning Validation Summit 2016

May 23-24, 2016, Racquet Club of Philadelphia, PA

Are you compliant with FDA requirements for cleaning validation? Today's regulators are applying more fine-grained specifications and demanding more sophisticated procedures for planning, executing, and documenting your processes throughout a drug product's lifecycle. This two-day intensive summit brings together industry leaders to help you exceed regulatory thresholds and avoid costly FDA inspection findings.

Extractables, Leachables, & Elemental Impurities

April 18-19th, 2016, Sheraton La Jolla, California

Attention to leachables, extractables, and elemental impurities has increased due to the recent revisions of USP and ICH guidelines. This two-day conference will examine the safety, quality, and regulatory issues involved in a wide array of contexts central to the pharmaceutical industry, including drug packaging and delivery components, single-use systems, parenteral drug products, and infusion pump systems. We will hear from key industry working groups such as PQRI and BPOG. In addition, we will focus closely on the keys to satisfying recent ICH and USP guidelines for metal impurities in current and future drug products and biologics.

2016 Pre-Filled Syringes Forum

April 4-5, 2016, Racquet Club of Philadelphia, PA

Pharma Ed Resources, an industry leader since 2004 in delivering market-driven research on pre-filled syringes, is proud to announce its 2016 Pre-Filled Syringes Forum. With the global market for PFS expected to top $6.5 billion dollars by 2020, the biopharmaceutical industry is looking for next generation materials, technologies and production strategies to streamline commercialization and to adapt quickly to a changing regulatory environment. That is why you cannot afford to miss this intensive two-day training event. Pharma Ed brings together top researchers and innovators to share best practices and the latest science, enabling you to maximize your organization's leverage in this dynamic and growing market.

Solubility & Bioavailability Summit 2015

Exploring New Strategies for Optimizing Bioavailability of Current and Future Drug Products

November 5-6, Racquet Club of Philadelphia, PA

Perhaps the most critical research agenda for today's pharmaceutical industry is achieving solubility and bioavailability of poorly soluble drug candidates. The challenges are not going away, and neither are your organization's demands. Pharma Ed's 3rd annual Solubility & Bioavailability Summit focuses on the innovative science required to overcome bioavailability/solubility challenges for API's in a wide range of pre-clinical, clinical, and manufacturing contexts.

Transdermal and Intradermal Drug Delivery Systems, 2015

May 11-12, 2015, Racquet Club of Philadelphia, PA

The growing interest in alternative routes of drug administration has experts predicting that the market for transdermal and intradermal drug delivery systems will exceed $30 billion in 2015. That's why you cannot afford to miss this two-day intensive conference. Pharma Ed brings together leading researchers in the field to share the most recent advances in the design, formulation, and delivery of skin-mediated therapies and vaccines.

Solubility & Bioavailability Summit 2014

Exploring New Strategies for Optimizing Bioavailability of Current and Future Drug Products

December 4-5, Racquet Club of Philadelphia, PA

Perhaps the most critical research agenda for today's pharmaceutical industry is achieving solubility and bioavailability of poorly soluble drug candidates. The challenges are not going away, and neither are your organization's demands. Pharma Ed's Solubility & Bioavailability Summit focuses on the innovative science required to overcome bioavailability/solubility challenges for API's in a wide range of pre-clinical, clinical, and manufacturing contexts.

Featuring Representation From:

Bayer

Bristol-Myers Squibb

AbbVie

Novartis

Ipsen BioScience

Astra Zeneca

Merck

Capsugel

Quotient Clinical

Kashiv Pharma

Pion

Sirius Analytical

H. Lundbeck

NIST

University of Limerick

Gattefossé

Center for Pharmaceutical Physics

Agere

University of the Sciences in Philadelphia

Featuring Comprehensive Coverage On:

Optimizing Formulations for New Drug Product Development

Peptide Formulation Challenges and Beyond

De-risking New Chemical Entities for Food- and pH-Sensitivity in Early Clinical
Development

Attention to leachables, extractables, and elemental impurities has increased due to the recent revisions of USP and ICH guidelines. This two-day conference will examine the safety, quality, and regulatory issues involved in a wide array of contexts central to the pharmaceutical industry, including drug packaging and delivery components, single-use systems, parenteral drug products, and infusion pump systems. We will hear from key industry working groups such as PQRI and BPOG. In addition, we will focus closely on the keys to satisfying recent ICH and USP guidelines for metal impurities in current and future drug products and biologics.

Featuring Comprehensive Coverage On:

Meeting Qualification and Compliance Implications of USP and and ICH Guidelines for Elemental Impurities

Industry Working Group Updates: The PQRI Leachables and Extractables Considerations for Parenteral and Ophthalmic Drug Products

Industry Working Group Updates: The BPOG's Extractables Protocols for Singe-Use Technologies

Total and Extractable Elemental Impurities In Plastic Materials and Systems: A Literature Review

Attention to leachables, extractables, and elemental impurities has increased due to the recent revisions of EMA, USP, and ICH guidelines. This two-day conference will examine the safety, quality, and regulatory issues involved in a wide array of contexts central to the pharmaceutical industry, including drug packaging and delivery components, single-use systems, parenteral drug products, and infusion pump systems. In addition, we will also focus closely on the keys to satisfying recent ICH, USP, and EMA guidelines for metal impurities in current and future drug products and biologics.